Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01072396
Recruitment Status : Completed
First Posted : February 22, 2010
Results First Posted : May 15, 2013
Last Update Posted : December 24, 2013
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of patients with predominantly severe and very severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits of tiotropium on exercise tolerance in a patients with early stages of COPD who are symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients) may benefit from maintenance therapy and there is limited data on exercise limitation in patients with early stage COPD who are symptomatic. This study is designed to evaluate the mechanisms of breathlessness and assess physical activity limitation in early stage COPD patients compared to age and gender matched controls and will secondly investigate the effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise duration as a result of the bronchodilation effects of tiotropium leading to a reduction of dynamic hyperinflation in Early Stage COPD patients.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Tiotropium Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, 6-week, Crossover Study to Examine the Effects of Tiotropium (Spiriva® HandiHaler®, 18 µg Once Daily) on Dynamic Hyperinflation and Physical Exercise Capacity in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : February 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 18 mcg tiotropium
Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
Drug: Tiotropium
double blind randomized crossover

Placebo Comparator: Placebo
Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
Drug: Placebo
inhalation powder capsule identical to those containing tiotropium bromide inhalation powder

No Intervention: Control
Age and gender matched control subjects to conduct incremental and constant work rate exercise tests for comparison to subjects with early stage COPD

Primary Outcome Measures :
  1. Change From Baseline in Inspiratory Capacity (IC) at Isotime [ Time Frame: baseline, six weeks of treatment ]
    Inspiratory capacity (IC) during CWR exercise testing measured at isotime (isotime was established during CWR exercise testing at baseline). Isotime is the minimum exercise time among all tests. Constant work rate exercise means the exercise is done under constant work rate.

Secondary Outcome Measures :
  1. Constant Work Rate (CWR) Endurance Time [ Time Frame: six weeks of treatment ]
    CWR exercise duration calculated as the length of time of the exercise period

  2. Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime [ Time Frame: baseline, six weeks of treatment ]
    Modified Borg Scale is a participant rating of the intensity of dyspnea measured on a scale ranging from 0 (Nothing at all) to 10 (Maximal, most severe ever experienced).

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

For COPD subjects: Male or female, age of 40 years or older, smoking history >10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio <70%., FEV1 >/=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.

Exclusion criteria:

Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.

Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.

Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a significant disease including COPD.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01072396

United States, Alabama
205.440.1006 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
205.440.1015 Boehringer Ingelheim Investigational Site
Jasper, Alabama, United States
United States, California
205.440.1002 Boehringer Ingelheim Investigational Site
Torrance, California, United States
United States, Connecticut
205.440.1018 Boehringer Ingelheim Investigational Site
Hartford, Connecticut, United States
United States, Illinois
205.440.1008 Boehringer Ingelheim Investigational Site
Springfield, Illinois, United States
United States, Indiana
205.440.1017 Boehringer Ingelheim Investigational Site
Muncie, Indiana, United States
United States, Michigan
205.440.1020 Boehringer Ingelheim Investigational Site
Livonia, Michigan, United States
United States, New Hampshire
205.440.1011 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire, United States
United States, North Carolina
205.440.1019 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
United States, Pennsylvania
205.440.1013 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
United States, South Carolina
205.440.1007 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
Canada, Ontario
205.440.2003 Boehringer Ingelheim Investigational Site
Kingston, Ontario, Canada
Canada, Quebec
205.440.2001 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
205.440.2004 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
205.440.2002 Boehringer Ingelheim Investigational Site
Ste-Foy, Quebec, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim Identifier: NCT01072396     History of Changes
Other Study ID Numbers: 205.440
First Posted: February 22, 2010    Key Record Dates
Results First Posted: May 15, 2013
Last Update Posted: December 24, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action